Cleaning device and method for fluid transfer connector

ABSTRACT

A cleaning swab device and method for cleaning a fluid coupling or connector. The device includes a generally elongate cylindrical tubular swab body, and a channel formed at an end thereof to define at least one cleaning finger for insertion into a housing and/or port of the connector to remove residual fluids, clean and disinfect the connector. The cleaning device optionally further includes a guide stem or plunger configured to extend through the tubular body of the swab, having a plug at one end for sealing debris out of a lumen of the connector during cleaning.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Non-Provisional patentapplication Ser. No. 15/009,073 filed Jan. 28, 2016, now U.S. Pat. No.9,931,176, which claims the priority benefit of U.S. Provisional PatentApplication Ser. No. 62/108,824 filed Jan. 28, 2015, which is herebyincorporated by reference herein.

TECHNICAL FIELD

The present invention relates generally to the field of medical devices,and more particularly to cleaning devices and methods for use with fluidtransfer connectors such as coupling connectors for enteral fluidcontainers.

BACKGROUND

Neonates and other healthcare patients are often administered fluidssuch as medications, nutritional fluids and supplements via enteralfluid delivery, commonly utilizing delivery systems including fluidcontainers, syringes, feeding tubes and other components. Thesecomponents are often interconnected by connectors or couplings such asLuer connectors, or the more recently developed ENFit connector (ISOStandard 80369).

In some embodiments, these enteral connectors or couplings may includeouter housing geometries with recesses or areas that could retain smallquantities of unused feeding fluids that might allow for bacteriacolonization or contain other potential contaminants. U.S. patentapplication Ser. No. 14/844,956, which is incorporated herein byreference, discloses a vented male ENFit enteral coupling or connectorhaving a housing structure with drainage passages or vents to eliminateor reduce the likelihood of retaining feeding liquids or othercontaminants in the outer housing. Further improvements in the field aredesirable, and it is to the provision of cleaning swab devices andmethods for enteral couplings or connectors that the present inventionis primarily directed.

SUMMARY

In example embodiments, the present invention provides cleaning swabdevices and methods for cleaning and/or disinfecting fluid transferconnectors or couplings, such as for example enteral feeding couplings.In example forms, the cleaning devices and methods are adapted forapplication with ENFit fluid transfer connectors in the form of maleENFit connectors, but the devices and methods of the present inventionmay likewise be adapted to use with other connectors or couplingformats.

In one aspect, the present invention relates to a cleaning device forcleaning a connector, the cleaning device including a generally elongatecylindrical swab member having a first end and a second end, the firstend generally opposite the second end, an opening defined within thecylindrical member and extending from the first end to the second end,and a channel formed within a portion of the cylindrical swab member todefine at least one finger, the at least one finger preferablycomprising a cleaning material to provide for cleaning and/ordisinfecting at least a portion of the connector.

In example embodiments, the at least one finger includes an interiorsurface, an exterior surface, an intermediate surface, and an endsurface. In one example embodiment, at least a portion of one or more ofthe surfaces are at least partially covered with a cleaning material toprovide for cleaning and disinfecting at least portions of theconnector. According to example embodiments, the cleaning material iscoated with a cleaning agent in the form of isopropyl alcohol, sterilewater, saline, soapy water, or other agent.

In another aspect, the invention relates to a cleaning device forcleaning near and within at least one vent of a vented connectorincluding a generally elongate cylindrical swab member having a firstend and a second end, the first end generally opposite the second end,an opening defined within the cylindrical swab member and extending fromthe first end to the second end, and a channel formed within a portionof the cylindrical swab member to define at least two fingers, the atleast two fingers at least partially comprising a material to providefor cleaning and disinfecting at least a portion of the ventedconnector; and a plunger extending from a first end to a second end, theplunger extending through the opening and comprising an actuating end atthe first end and a plug end at the second end.

In example embodiments, the at least two fingers comprise interiorsurfaces, exterior surfaces, intermediate surfaces, and end surfaces. Inone example embodiment, at least a portion of one or more of thesurfaces are at least partially covered with a cleaning material toprovide for cleaning and disinfecting at least portions of the ventedconnector. In another example embodiment, the cleaning material iscoated with a cleaning agent in the form of isopropyl alcohol, sterilewater, saline, soapy water, or other agent.

In still another aspect, the invention relates to a cleaning device forcleaning and/or disinfecting a connector, the connector including a stemhaving a lumen extending therethrough, an outer housing, and threadspositioned on an internal portion of the outer housing, the cleaningdevice including a generally elongate tube extending from a first end toa second end and including an opening axially extending therethrough,wherein at least one end of the cleaning device can be inserted betweenthe stem and the threads of the outer housing to clean and disinfect theconnector.

In example embodiments, at least one end of the generally elongate tubeincludes a channel formed with a portion thereof to define at least onecleaning finger. The at least one cleaning finger includes an interiorsurface, an exterior surface, an intermediate surface and an endsurface. In one example embodiment, one or more of the surfaces are atleast partially covered with a cleaning material to provide for cleaningand disinfecting at least portions of the connector.

In yet another aspect, the invention relates to a cleaning device forcleaning and/or disinfecting a connector, the connector including a stemhaving a lumen extending therethrough, an outer housing, threadspositioned on an internal portion of the outer housing, the connectorfurther including a cap having a generally rib-like body, a seal plugextending from the rib-like body, and a tether connecting the cap to theconnector, the seal plug generally provided for sealingly engaging thelumen of the stem. The cleaning device includes a generally elongatetube extending from a first end to a second end and having an openingaxially extending therethrough, the cleaning device further including achannel formed with a portion of the cylindrical member to define atleast one finger, wherein the at least one finger of the cleaning devicecan be inserted between the stem and the threads of the outer housing toclean and disinfect the connector with or without the seal plugsealingly engaging the lumen of the stem.

In still another aspect, the invention relates to a method of cleaningand/or disinfecting a connector. The connector generally includes a stemhaving a lumen extending therethrough, an outer housing, and threadspositioned on an internal portion of the outer housing. The methodincludes providing a cleaning device having a generally elongatecylindrical member including a first end and a second end, the first endgenerally opposite the second end, and an opening defined within thecylindrical member and extending from the first end to the second end;engaging an end of the cleaning device with the connector, the end ofthe cleaning device generally being positioned between the stem and thethreads of the connector; translating and/or rotating the cleaningdevice relative to the connector while the end of the cleaning device isengaged with the connector; and disengaging the cleaning device from theconnector.

In yet another aspect, the invention relates to a cleaning device forcleaning a connector. The cleaning device includes a generally elongatehousing, at least one brush member, and a plunger movably mounted to thehousing. The housing includes a central opening extending therethrough.The at least one brush member is generally mounted to the housing and isgenerally laterally offset from the central opening. In example forms,the housing is generally cylindrical in shape and comprises a pair offlanges formed at an end thereof. In example forms, a pair ofdiametrically opposed channels are defined between the flanges.According to one example form, the at least one brush is mounted to thehousing and is recessed within an orifice defined by the flanges, andwherein the channels defined between the flanges allow for theapplication of a cleaning agent to the at least one brush when a portionof the plunger is engaged with a portion of the connector.

In still another aspect, the invention relates to a cleaning device forcleaning a connector. In example embodiments, the connector includes astem and a lumen extending therethrough. In example embodiments, thecleaning device includes a handle defining a longitudinal central axis,at least one brush mounted to the handle, a plunger coupled to thehandle and generally extending along the longitudinal central axis.

In example embodiments, the at least one brush is positioned generallyparallel to and laterally offset from the longitudinal central axis. Inexample embodiments, an end of the plunger is configured for projectingbeyond an end of the handle for engagement with the stem of theconnector. In example embodiments, the plunger is configured for sealingengagement with the lumen of the stem. In example embodiments, theconnector further includes an outer housing surrounding the stem and aspace defined between the stem and outer housing, and wherein with theplunger sealingly engaged with the lumen the at least one brush canoccupy at least a portion of the space to clean the space. In exampleembodiments, the plunger is sized and shaped for sealing engagement witha lumen of an ISO 80369-3 formatted connector. In example embodiments,the ISO 80369-3 formatted connector includes a male EN Fit connector. Inexample embodiments, at least two brushes are mounted to the handle. Inexample embodiments, the at least one brush and plunger are mounted tothe handle to extend in a generally similar direction. In exampleembodiments, the plunger is configured for extending at least partiallybeyond an end of the at least one brush.

In yet another aspect, the invention relates to a cleaning device forcleaning and/or disinfecting a connector. The connector includes a stemhaving a lumen extending therethrough, an outer housing and threadspositioned on an internal portion of the outer housing. The cleaningdevice includes a generally elongate handle extending from a first endto a second end along a longitudinal axis, and a plunger and at leastone brush mounted to the elongate handle, wherein the at least one brushcan be inserted between the stem and the threads of the outer housing toclean the connector.

In example embodiments, the at least one brush is inserted between thestem and the threads, the plunger sealingly engages with the lumen. Inexample embodiments, an end of the plunger is configured for extendingat least partially beyond an end of the at least one brush. In exampleembodiments, the connector includes an ISO 80369-3 formatted connector.In example embodiments, the ISO 80369-3 formatted connector includes amale ENFit connector. In example embodiments, at least two brushes aremounted to the handle. In example embodiments, the at least one brushand plunger are mounted to the handle to extend in a generally similardirection.

In still another aspect, the invention relates to a cleaning device forcleaning a connector. The connector including a stem having a lumenextending therethrough. The cleaning device includes a handle configuredto be gripped by a user for application of the cleaning device intooperative engagement with the connector, a plunger coupled with thehandle and configured for engagement with the lumen of the connectorwhen the cleaning device is applied into operative engagement with theconnector, and at least one brush coupled with the handle and laterallyoffset from the plunger, whereby the brush engages externally around thestem when the cleaning device is applied into operative engagement withthe connector.

In example embodiments, the plunger is sized and shaped for sealingengagement with a lumen of an ISO 80369-3 formatted connector. Inexample embodiments, the ISO 80369-3 formatted connector includes a maleENFit connector. In example embodiments, an end of the plunger isconfigured for extending at least partially beyond an end of the atleast one brush. In example embodiments, the at least one brush andplunger are coupled to the handle such that they extend in a generallysimilar direction. In example embodiments, at least two brushes aremounted to the handle.

These and other aspects, features and advantages of the invention willbe understood with reference to the drawing figures and detaileddescription herein, and will be realized by means of the variouselements and combinations particularly pointed out in the appendedclaims. It is to be understood that both the foregoing generaldescription and the following brief description of the drawings anddetailed description of the invention are exemplary and explanatory ofexample embodiments of the invention, and are not restrictive of theinvention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of an assembled cleaning deviceaccording to an example embodiment of the present invention.

FIG. 2 shows a disassembled perspective view of the cleaning device ofFIG. 1.

FIG. 3 shows a front perspective view of the cleaning device of FIG. 1.

FIG. 4 shows the cleaning device of FIG. 1, showing a portion thereofdefining an area wherein foam or other cleaning material is applied.

FIG. 5 shows the cleaning device of FIG. 1, indicating a tip portionthereof wherein foam or other cleaning material is applied.

FIGS. 6-10 show a sequence of operation using the cleaning device ofFIG. 1 to clean a connector, according to an example method of thepresent invention.

FIG. 11 shows a cleaning device according to another example embodimentof the present invention, and a connector with which the cleaning devicemay be utilized.

FIG. 12 shows an end view of the connector of FIG. 11.

FIGS. 13-14 show a sequence of operation using the cleaning device ofFIG. 11 to clean the connector, according to another example method ofthe present invention.

FIG. 15 shows a cleaning device engaged with a portion of a connector,according to another example embodiment of the present invention.

FIG. 16 shows a front perspective view of a cleaning device according toanother example embodiment of the present invention, showing the plungerthereof in a retracted state.

FIG. 17 shows a rear perspective view of the cleaning device of FIG. 16.

FIG. 18 shows a front perspective view of the cleaning device of FIG.16, showing the plunger in the extended state.

FIG. 19 shows a front perspective assembly view of the cleaning deviceof FIG. 16.

FIG. 20 shows a rear perspective assembly view of the cleaning device ofFIG. 19.

FIG. 21 shows a side view of the cleaning device of FIG. 18.

FIG. 22 shows a cross sectional view of the cleaning device of FIG. 21taken along line 22-22.

FIG. 23 shows a perspective view of the plunger of the cleaning deviceof FIG. 16.

FIG. 24 shows a perspective view of a brush member of the cleaningdevice of FIG. 16.

FIGS. 25A-26 show further examples of connectors or couplings to whichthe cleaning swab assemblies and methods of the present invention may beapplied.

DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

The present invention may be understood more readily by reference to thefollowing detailed description of the invention taken in connection withthe accompanying drawing figures, which form a part of this disclosure.It is to be understood that this invention is not limited to thespecific devices, methods, conditions or parameters described and/orshown herein, and that the terminology used herein is for the purpose ofdescribing particular embodiments by way of example only and is notintended to be limiting of the claimed invention. Any and all patentsand other publications identified in this specification are incorporatedby reference as though fully set forth herein.

Also, as used in the specification including the appended claims, thesingular forms “a,” “an,” and “the” include the plural, and reference toa particular numerical value includes at least that particular value,unless the context clearly dictates otherwise. Ranges may be expressedherein as from “about” or “approximately” one particular value and/or to“about” or “approximately” another particular value. When such a rangeis expressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment.

With reference now to the drawing figures, wherein like referencenumbers represent corresponding parts throughout the several views,example embodiments of the invention will be described. FIGS. 1-5 show acleaning device or swab assembly 10 according to an example embodimentof the present invention. In this embodiment, the cleaning device 10generally comprises a swab member 20 and a guide shaft or plunger 40.The swab 20 comprises an elongate cylindrical tube member or handle 22,and extends from a first end 26 to a second end 30. In exampleembodiments, an opening or lumen 24 extends through the swab 20 from thefirst end 26 to the second end 30. As depicted in FIG. 3, the first endof the swab 20 generally includes a wall or end portion 31 formed withthe swab 20 and defines the opening 24 formed generally at a centralportion thereof. The second end 30 of the swab 20 generally includes atleast one elongate channel 32 (in the depicted embodiment, twodiametrically opposed cutout portions of the tubular body of the swab 20define the channel 32), forming a pair of projections or swab fingers 34at the second end 30 of the swab 20, the projections 34 being configuredto extend within an outer housing of a connector (and/or within and/orthrough drainage openings or vents of the connector) to clean anddisinfect the connector whereby any residual feeding liquids or otherdebris retained within the connector is removed.

The projections 34 are shown in greater detail in FIGS. 4-5. In exampleforms, the projections 34 comprise interior surfaces 35, exteriorsurfaces 37, intermediate surfaces 36, and end surfaces 38. In exampleembodiments, at least a portion of one or more of the surfaces 35, 36,37, 38 are at least partially covered with a foam material, flocking, orother cleaning material CM to provide for cleaning and disinfecting atleast portions of the connector during its cycle of use. The foammaterial CM can optionally be coated with isopropyl alcohol (ISP) orother forms of antimicrobial, antibacterial or otherdisinfecting/cleaning agents. In example forms, the cleaning agentcomprises 70% ISP. Alternatively, other cleaning agents such as sterilewater, saline, soapy water, or other agents may be utilized. The foam orother cleaning material CM is preferably compressible, absorbent andtextured to facilitate a scrubbing action against portions of theconnector. According to some example forms, the cleaning material CM isin the form of a brush, for example, wherein a generally rigid wirecomprising a plurality of bristles extending therefrom is provided forcontacting and cleaning/disinfecting the connector (as will be describedbelow).

Referring back to FIG. 2, the plunger 40 generally comprises a rod orshaft having an actuating or gripping portion such as a flange 50 formedat a first end thereof and a plug or tip portion 52 formed at a secondend thereof. The actuating portion generally comprises a gripping pad orenlarged surface area 46 and the plug portion formed at the second endof the plunger 40 is configured for insertion and sealing within a lumenof the connector (as will be described below). In example embodiments,the flange 50 is sized to be larger than the opening 24 of the swab 20to prevent the swab from being retracted over the flange and off of theplunger.

FIGS. 6-10 show a sequence of operation of the cleaning device used toclean a connector 60 according to an example method of use of thepresent invention. In the depicted embodiment, the connector 60 isgenerally in the form of the connector disclosed in U.S. patentapplication Ser. No. 14/844,956, which is incorporated herein byreference and shows an improved male ENFIT connector for enteral fluidcontainers and vessels that includes vent or drain openings to reducethe incidence of residual feeding liquids being retained within theouter housing 70 thereof where bacterial growth or contamination mightoccur. The connector 60 comprises a front end, the stem 66 (comprising alumen extending therethrough), the outer housing 70, threads 372positioned on an internal portion of the outer housing 70 (see FIG.25A), a pair of vent openings 174 (see FIG. 12), a cap 80, a tether 82attaching the cap 80 to the connector 60, a handle 83 for gripping thecap 80, a body 84, and a seal plug 86.

As shown in FIG. 6, the swab 20 is mounted over the plunger 40 with theplug end 52 of the plunger projecting outwardly from the second end 30of the swab 20. The plug 52 is removably inserted into the lumen of themale connector stem 66 of the connector 60 to seal the lumen extendingthrough the stem 66. According to example forms, the plug sealinglyengaging the lumen preferably prevents contamination of the lumen fromdebris or the cleaning agent during the cleaning process (as will bedescribed below). In example forms, a user's thumb or finger may pressagainst the pad 46 and/or flange 50 to force the plug 52 to removablyand sealingly engage the lumen. According to some example forms, theplug 52 is generally sized and shaped similarly to the seal plug 86 ofthe cap 80.

Once the plug is inserted and sealed within the lumen of the connectorstem 66, the swab 20 is advanced in a traversing or translationalmovement along the plunger 40 such that the projections 34 begin to movebetween the outer housing 70 and the connector stem 66. As shown in FIG.7, the projections 34 are generally positioned between the outer housing70 and the stem 66 so that the swab 20 is capable of rotation about theplunger 40, thereby allowing the projections 34 to rotationally movetherebetween to clean and/or disinfect (e.g., removing any feedingfluids or other debris and potential contaminants that may be containedtherein). Next, as shown in FIG. 8, the swab 20 is further advancedalong the plunger 40 such that the projections 34 extend through thevent openings 74 of the connector 60 to further clean and/or disinfectthe connector and remove any feeding fluid or residue present due tofluid drainage through the vent openings 74. Thus, by having the plugsealingly engaged with the lumen of the stem 66, debris and/or thecleaning agent of the projections 34 (or foam material CM thereof) areprevented from being introduced into the lumen when cleaning (e.g.,translational and/or rotational motion of the swab 20 whereby theprojections 34 are generally positioned between the outer housing 70 andthe connector stem 66).

As shown in FIG. 9, the swab 20 can then be retracted rearward, causingthe projections 34 to be withdrawn from the vent openings 74 and frombetween the stem 66 and outer housing 70. The plug end 52 of the plunger40 preferably remains inserted in the lumen of the connector stem 66while the swab 20 is withdrawn from the connector 60 to preventcontamination that may be present on the swab from entering the lumen ofthe connector stem. After the swab is withdrawn, the plug 52 isdisengaged from the lumen of the connector stem 66 as shown in FIG. 10.In example forms, traversing the swab 20 along the plunger 40 isgenerally carried out by grasping a portion of the tube 22, and engagingand disengaging the plug 52 to/from the lumen of the connector stem 66is carried out by pressing or pulling on the actuating end of theplunger 40 (e.g., the pad 46 and/or flange 50). After the plug 52 isdisengaged from the lumen of the connector stem 66, the seal plug 86 ofthe cap 80 can then be inserted into the lumen of the connector stem 66so that further contamination therein is prevented.

Optionally, according to additional example embodiments of the presentinvention, the channel 32 of the swab 20 can be configured to follow agenerally helical path such that the pair of projections 34 generallyfollow a helical path, for example, instead of the projections 34 beinggenerally linear as depicted. In this manner, the projections 34 canstill be positioned between the outer housing 70 and the stem 66 so thatthe swab 20 is capable of rotation about the plunger 40, therebyallowing the projections 34 to rotationally move therebetween to cleanand/or disinfect (e.g., removing any feeding fluids or other debris andpotential contaminants that may be contained therein). Furthermore, whenthe swab 20 is further advanced along the plunger 40 such that theprojections 34 extend through the vent openings 74, the swab 20 isrotated (and translated) to cause greater or less engagement with thevent openings 74, for example, since the channel 32 follows a helicalpath. Thus, in example forms, rotational movement can be provided forcleaning of the connector when the projections 34 are positioned betweenthe outer housing 70 and the stem 66 and when the projections 34 movethrough the vent openings 74.

FIGS. 11-14 show a cleaning device or swab assembly 110 comprising aswab 20 substantially as described above, and a modified coupling orconnector 160 according to another example embodiment of the presentinvention. The connector 160 comprises a cap 180 comprising a generallyflanged or rib-like body 184 and a seal plug 186 extending therefrom(shown as being fully inserted within the lumen of the stem 166). Inexample embodiments, a tether 182 optionally connects the cap 180 to theconnector 160, as similarly described above. Preferably, rather thanproviding a plunger for sealing the lumen of the connector stem 166, theseal plug 186 is utilized to seal the lumen while also allowing theprojections 34 of the swab 20 to be inserted between the outer housing170 and the stem 166. As depicted in FIG. 12, the rib-like body 184 ofthe cap 180 is preferably configured, sized and shaped to fit within thechannel 32 of the swab 20 and to allow the projections 34 to extendwithin the connector, between the outer housing 170 and the stem 166(see FIG. 13), and within and through the vent openings 174 (see FIG.14). Preferably, as shown in FIG. 13, when the projections 34 areinserted within the connector 160 (between the outer housing 170 and thestem 166), the body 184 of the cap 180 is received within the channel32. In an example manner of use, the seal plug 186 remains sealinglyengaged with the lumen of the stem 166, and the swab 20 can be rotatedto clean within the housing and vent openings, which causes the plug 180and tether 182 to rotate therewith. As depicted in FIG. 14, the swab 20can be further advanced within the connector 160 such that theprojections 34 extend through the vent openings 174. In example forms,since the seal plug 186 is plugging the lumen rather than the plunger 40as described above, the channel 32 of the swab may be sized accordingly(e.g., width, length, etc.) to provide for fitting around the body 184and permitting adequate extension of the projections 34 through the ventopenings 174.

FIG. 15 shows another method of use of the swab 20 to clean a connector60 according to the present invention. As depicted, the swab 20 isapplied for cleaning the connector 60 without the use of the plunger 40or seal plug 86 to seal the lumen of the connector stem 66, for examplewhen the risk of debris entering the lumen of the connector stem issmall or is not of concern (e.g., a final wipe-down to remove residualfluid after use of the connector is complete, prior to disposal).

FIGS. 16-22 show a cleaning device 210 according to another exampleembodiment of the present invention. As depicted, the cleaning device210 generally comprises a housing 212, at least one brush member 230mounted to the housing 212, and a guide shaft or plunger 240. Accordingto one example form, the housing 212 comprises a first housing half orshell 214 and a second housing half or shell 216, wherein the housingshells 214, 216 are generally similarly sized and shaped about an axisof symmetry, and whereby one or more snap fittings, crush pins,connectors or other coupling features thereof provide for joining thetwo shells 214, 216 together to form the housing 212. According toexample forms, the housing 212 is generally cylindrical in shape andcomprises a first end having a generally recessed area for receiving aportion of the plunger 240 (as will be described below) and a second endcomprising a pair of generally elongate and oppositely-positionedflanges 224 defining an enlarged orifice 221 within the housing 212.According to example forms, the plug 252 of the plunger 240 isconfigured to be engaged with the lumen of the connector to be cleaned,and the housing 212 and brushes 230 attached thereto are configured tomove along the plunger 240 so that the brushes can move within the outerhousing and along an exterior of the stem of the connector so that thebrushes 230 are capable of rotation about the plunger 240, therebyallowing the brushes 230 to rotationally move therebetween (e.g.,between an outer portion of the stem and against an interior wall of theouter housing of the connector) to clean and/or disinfect (e.g.,removing any feeding fluids or other debris and potential contaminantsthat may be contained therein).

As depicted in FIGS. 19-22, the shells 214, 216 comprise generallyelongate channels 223A-D for receiving a rod portion 232 of the brushes230 (see FIG. 24). According to example forms, the channels 223A-D aregenerally parallel and laterally offset a small distance from a centralchannel 222 defining a longitudinal central axis X that generallyextends between the ends of the housing 212, for example, which providesfor capturing a retaining feature 254 of the plunger 240, for example,to permit translation of the plunger 240 relative to the housing 212,and to also permit rotation of the housing 212 relative to the plunger240. Preferably, the shells 214, 216 comprise one or more couplingfeatures for providing engagement therebetween, for example, to form thehousing 212. According to one example form, the coupling features are inthe form of female projection elements 225 formed in the first housingshell 214 and male projection elements 226 formed in the second housingshell 216. As depicted in FIGS. 19-20, the coupling elements 225, 226are generally positioned along at least a majority of the length of thehousing (near the outer periphery thereof), and provide a snap fitengagement together, for example, to provide a generally elongate,cylindrical housing member 212. One of ordinary skill in the art willappreciate that the housing shells 214, 216 can couple together in aplurality of different formats and can comprise a plurality of differentengagement features. Alternatively, the housing 212 is generally formedfrom one integrally formed, unitary member, for example, rather than twoseparate half-shell pieces. In further alterative embodiments, the outerhousing shells are generally hingedly connected together, for example,such that the shells are capable of pivoting relative to each otherbetween an open configuration and a closed, snapped-togetherconfiguration.

As depicted in FIGS. 16-17, the plug 252 of the plunger 240 is generallyin a retracted state within a portion of the housing and generallyadjacent the flanges 224. In the retracted state, the plug 252 isgenerally intended to be engaged with the lumen of the connector suchthat the brushes 230 (generally laterally offset or spaced outwardlyrelative to the plug 252) can fully extend between the stem and theouter housing of the connector. As depicted in FIGS. 18 and 21-22, theplunger 240 is in the extended state wherein the plug 252 extends beyondthe ends of the flanges 224. Generally described, the actuating portion,gripping pad or end portion 246 (comprising the flange 250) is generallyfitted within the recessed area of the first end of the housing 212.Generally, when the cleaning device is not in use, the plug 252 remainsin the extended state—projecting outwardly from the second end of thehousing 212 beyond the flanges 224. In example forms, the flanges 224are sized and shaped such that generally elongate, diametrically opposedchannels 220 are defined along a portion of the housing, for example,generally starting at the second end of the housing 212 and extendingtowards the first end. In example forms, the channels provide access tothe orifice 221 of the housing 212, for example, where the brushes 230are positioned. As will be described below, the channels preferablyprovide for the application of a cleaning agent to the brushes 230 whenthe plug 252 is engaged with the lumen of the connector.

The plunger 240 generally comprises the end portion 246 having theflange 250 and a plug 252 at an end generally opposite the end portion246 for engaging the lumen. The retaining feature 254 is generallypositioned on a portion of the plunger 240 between the ends. Generally,the retention feature 254 is an outwardly-extending, skirt-likeprojection, which is preferably sized and shaped to movably mount withinthe central channel 222 of the housing 212. Preferably, the retentionfeature 254 is sized and shaped such that the plunger 240 is capable oftranslational and rotational movement relative to the housing 212, forexample, to allow the housing 212 and brushes fixed relative to thehousing 212 to move along the plunger rod once the plug 252 is engagedwith the lumen of the connector. However, the retention feature 254prevents the plunger 240 from becoming disengaged from the housing 212.

In example forms, each brush 230 generally comprises an elongate rod232, whereby at least a portion of the rod 232 comprises a circulararray of bristles 234 extending therefrom. According to example forms,the brush 230 comprises a circular array of about nine (9) linear arraysof bristles 234. According to one form, the length of each linear arrayof bristles 234 is generally between about 4-25 millimeters, for examplebetween about 8-20 millimeters, and in a particular example about 14millimeters. The entire length of the brush 230 is generally betweenabout 10-50 millimeters, for example between about 20-40 millimeters,and in a particular example about 30.8 millimeters. According to exampleforms, the length of each bristle 234 is generally between about 1-5millimeters, for example between about 2-4 millimeters, and in aparticular example about 2.35 millimeters. According to example forms,the bristles 234 may be formed from any desired material. According toone example form, the bristles 234 are formed from a nylon filament, forexample, DuPont Tynex® 612 nylon filament.

In use, the cleaning device 210 is provided for cleaning anddisinfecting the area of the connector between the stem and outerhousing portion. With the plunger in the extended state, the plug 252 isengaged with the lumen of the connector, and then the housing (andbrushes 230 affixed thereto) are permitted to move along the length ofthe plunger 240 such that the bristles 234 extend within the connectorbetween the stem and outer housing thereof. This causes the plunger 240to be moved to the retracted state wherein the plug 252 is generallyrecessed within housing 212 near the second end (see FIGS. 16-17). Inexample forms, the flanges 224 of the housing are generally sized andshaped to permit the outer housing of the connector to be fittedtherein, and wherein the brushes 230 (generally laterally offset fromthe flanges 224 and plug 252) are appropriately positioned to fitbetween the stem and an internal surface or wall of the outer housing ofthe connector. The housing 212 is then rotated around the plunger 240(with the plug 252 engaged with the lumen) to clean and disinfect theconnector. Once the cleaning and disinfecting of the connector has beenperformed, the user can disengage the cleaning device 210 from theconnector by grasping the housing 212 and pulling away from theconnector. Optionally, once the plug 252 of the plunger 240 is engagedwith the lumen, and prior to the housing and brushes moving along theplunger 240 to clean and disinfect the connector, a cleaning agent canbe applied to the bristles 234 of the brushes 230 through the channels220. Thus, the cleaning device is configured such that a cleaning agentcan be applied to the brushes 230 while in the connected state with thelumen of the stem.

In alternate embodiments, one, two, or more brushes can be mounted tothe housing 212. Furthermore, the length of the brushes 230 and thebristles 234 may be longer or shorter in alternate embodiments.According to some example forms, multiple brushes having different brushlengths and bristle lengths may be provided for interchangeable orreplaceable installation in the housing 212. Further optionally, thebrushes may be mounted to the housing 212 by various different couplingmeans. For example, the brushes may be integrally formed with thehousing 212 or formed with the housing 212 (or shells thereof) duringthe molding process, for example, by over molding.

FIGS. 25A-26 show further details of a connector 360 according toexample embodiments to which the cleaning swab devices (includingbrushes) and methods of the present invention may be applied, asdescribed above. In example forms, the connector 360 is generally in theform of a male ENFit connector according to ISO 80369 standards, whichcomprises a stem 366 (comprising a lumen extending therethrough), anouter housing 370, and threads 372 formed on an internal portion of theouter housing 370. Generally, a tube T is coupled to a rear end portionthereof (and in communication with the lumen of the stem 366), whichprovides a conduit or path through which the feeding fluids flow.According to example forms, the connector 360 may be generally sized andshaped similarly to the connector 60 as described above. In one exampleembodiment, a swab 20 as shown above is used with or without a plunger40 in similar fashion to the above described methods to clean theconnector 360. According to another example form, a swab 20 without theelongate channel 32 (see dashed lines of FIG. 2 depicting the end of thetube 22 without the elongate channel 32) can be used with the connectors60, 160, 360 to clean and disinfect the same, particularly when theconnector does not include drainage or vent openings.

According to another example embodiment, the present invention relatesto a method of cleaning and/or disinfecting a connector. As describedabove, the connector comprises a stem having a lumen extendingtherethrough, an outer housing, and threads positioned on an internalportion of the outer housing. The method comprises providing a cleaningdevice comprising a generally elongate cylindrical swab membercomprising a first end and a second end, the first end generallyopposite the second end, and an opening defined within the cylindricalmember and extending from the first end to the second end; engaging anend of the swab with the connector, the end of the swab generally beingpositioned between the stem and the threads of the connector;translating and/or rotating the swab relative to the connector while theend of the swab is engaged with the connector; and disengaging the swabfrom the connector.

While the invention has been described with reference to preferred andexample embodiments, it will be understood by those skilled in the artthat a variety of modifications, additions and deletions are within thescope of the invention, as defined by the following claims.

What is claimed is:
 1. A cleaning device for cleaning a connector, the connector comprising a stem and a lumen extending therethrough, the cleaning device comprising: a handle defining a longitudinal central axis; at least one brush mounted to the handle; and a plunger coupled to the handle and generally extending along the longitudinal central axis, the plunger defining a first end and second end, the plunger comprising an actuating end at the first end such that the plunger can move along the longitudinal central axis.
 2. The cleaning device of claim 1, wherein the at least one brush is positioned generally parallel to and laterally offset from the longitudinal central axis.
 3. The cleaning device of claim 1, wherein the second end of the plunger is configured for projecting beyond an end of the handle for engagement with the stem of the connector.
 4. The cleaning device of claim 3, wherein the plunger is configured for sealing engagement with the lumen of the stem.
 5. The cleaning device of claim 1, wherein the connector further comprises an outer housing surrounding the stem and a space defined between the stem and outer housing, and wherein with the plunger sealingly engaged with the lumen the at least one brush can occupy at least a portion of the space to clean the space.
 6. The cleaning device of claim 1, wherein the plunger is sized and shaped for sealing engagement with a lumen of an ISO 80369-3 formatted connector.
 7. The cleaning device of claim 6, wherein the ISO 80369-3 formatted connector comprises a male ENFit connector.
 8. The cleaning device of claim 1, further comprising at least two brushes mounted to the handle.
 9. The cleaning device of claim 1, wherein the at least one brush and plunger are mounted to the handle to extend in a generally similar direction.
 10. The cleaning device of claim 9, wherein the second end of the plunger is configured for extending at least partially beyond an end of the at least one brush.
 11. A cleaning device for cleaning and/or disinfecting a connector, the connector comprising a stem having a lumen extending therethrough, an outer housing and threads positioned on an internal portion of the outer housing, the cleaning device comprising: a generally elongate handle extending from a first end to a second end along a longitudinal axis; a plunger extending along the longitudinal axis and defining a first end and second end, the plunger comprising an actuating end at the first end such that the plunger can move along the longitudinal central axis; and at least one brush mounted to the elongate handle, wherein the at least one brush can be inserted between the stem and the threads of the outer housing to clean the connector.
 12. The cleaning device of claim 11, wherein when the at least one brush is inserted between the stem and the threads, the plunger sealingly engages with the lumen.
 13. The cleaning device of claim 11, wherein the second end of the plunger is configured for extending at least partially beyond an end of the at least one brush.
 14. The cleaning device of claim 11, wherein the connector comprises an ISO 80369-3 formatted connector.
 15. The cleaning device of claim 14, wherein the ISO 80369-3 formatted connector comprises a male ENFit connector.
 16. The cleaning device of claim 11, further comprising at least two brushes mounted to the handle.
 17. The cleaning device of claim 11, wherein the at least one brush and plunger are mounted to the handle to extend in a generally similar direction.
 18. A cleaning device for cleaning a connector, the connector comprising a stem having a lumen extending therethrough, the cleaning device comprising: a handle configured to be gripped by a user for application of the cleaning device into operative engagement with the connector, the handle defining a longitudinal central axis; a plunger coupled with the handle and configured for engagement with the lumen of the connector when the cleaning device is applied into operative engagement with the connector, the plunger defining a first end and second end, the plunger comprising an actuating end at the first end such that the plunger can move along the longitudinal central axis; and at least one brush coupled with the handle and laterally offset from the plunger, whereby the brush engages externally around the stem when the cleaning device is applied into operative engagement with the connector.
 19. The cleaning device of claim 18, wherein the plunger is sized and shaped for sealing engagement with a lumen of an ISO 80369-3 formatted connector.
 20. The cleaning device of claim 19, wherein the ISO 80369-3 formatted connector comprises a male ENFit connector.
 21. The cleaning device of claim 18, wherein the second end of the plunger is configured for extending at least partially beyond an end of the at least one brush.
 22. The cleaning device of claim 18, wherein the at least one brush and plunger are coupled to the handle such that they extend in a generally similar direction.
 23. The cleaning device of claim 18, further comprising at least two brushes mounted to the handle. 